Tryp Therapeuatics (TRYPF) Coverage Report

Tryp’s clinical plans in chronic pain. TRYP is on track to become the first company to evaluate psilocybin for these three pain indications. As described above, there are several mechanisms by which psychedelics can be useful for chronic pain-related disorders, and each of these disorders while grouped as chronic pain have differences in their pathophysiology. Therefore, TRYP has three shots on target for chronic pain-related disorders.  Fibromyalgia (FM). Tryp plans to conduct a Phase 2a single-arm trial to establish proof-of-concept for the efficacy of psilocybin (TRP-8802) in FM. The trial will be conducted at the Chronic Pain & Fatigue Research Center in the Department of Anesthesiology at the University of Michigan Medical School and the Principal Investigator for the trial will be Kevin Boehnke, Ph.D., Research Investigator, University of Michigan Department of Anesthesiology. The company expects to file the IND for the trial in 3Q’21, with first dosing of patients to start in 1Q’22 (n=20).  Phantom limb pain (PLP) . Tryp plans to conduct a Phase 2a randomized, placebo-controlled, proof-of-concept trial to evaluate the efficacy of TRP-8802. Tryp has partnered with an undisclosed research institute in California who will be funding the trial partially with a grant they have received through a private organization. Tryp is expected to disclose the identity of the partner in 4Q’21. The company has already filed the IND for the trial in 3Q’21, with first dosing of patients to start in 4Q21 (n=50).  Complex regional pain syndrome (CRPS). Tryp plans to conduct a Phase 2a proof-of-concept trial to evaluate the efficacy of TRP-8802. Tryp has partnered with another research institute in California who will conduct the trial. Tryp will disclose the identity of the partner in 4Q.21. The company has already filed the IND for the trial in 1Q’22, with first dosing of patients to start in 1Q’22 (n=10). Unless otherwise noted above, Tryp’s Phase 2a proof-of-concept trials share the following characteristics:  The Phase 2a’s are using TRP-8802, which are non-proprietary, synthetic 25mg psilocybin capsules. Dependent on the outcome of the Phase 2a interim analyses, the Phase 2b’s will test Tryp’s proprietary synthetic formulation of psilocybin, TRP-8803.  The Phase 2a’s will include patients 21-to-70-years-old.  Primary endpoints readouts are expected one quarter after the undisclosed, predefined number of patients two months after initial dosing. Secondary endpoints are to be readout ~six months last patient was dosed.  The Phase 2a studies are all single-site trials while management is looking for the Phase 2b’s to be multi-site, placebo-controlled, randomized trials.  Tryp is fully funding the fibromyalgia and CRPS trials.  Interim data for all trials are expected in 2H22 and full data readouts are expected in 1H24. Michael Higgins 212.409.2074 Tryp Therapeutics, Inc. (TRYPF) Page 31